Regulatory Affairs Outsourcing Services Market

Market Insights

Growing regulatory pressure and the challenge of litigation over adverse or side effects, rapidly changing demographic patterns, dwindling product pipelines, and consistent growth in competition from generic manufacturers are just a few of the major challenges confronting the life sciences industry.

Further growth in the cost of drug development, approvals and growing responsibilities and obligations on the regulatory front have driven organizations to adopt outsourcing services for regulatory operations. These activities are proven to result in improved cost efficiencies while manufacturers become more focused on their core competencies. Diversification of several ancillary activities allows organizations to focus on improving their core businesses while third-party vendors deliver optimal services.

Some major advantages derived from regulatory affairs outsourcing include increased speed of market approvals, effective maintenance of product success in new and emerging markets, and swift and convenient extension of brand indications and formulations. Regulatory affairs outsourcing is also a high advantage for midsize and small companies that lack expertise in certain departments. This also reduced the workload on the employees and management while also ensuring appropriate, timely, and prompt regulatory submissions.

Market Synopsis

Regulatory writing and publishing are expected to be the major revenue generators, while clinical trial and product registration services will pick up pace within the forecast period.

Among the major regulatory affairs outsourcing services, regulatory writing and publishing occupy the largest revenue share in the global market. As the global market is condensing, there is prominent visibility of distinct regulatory scenarios in different regions. Companies domiciled in Europe and North America often face challenges in terms of regulatory submissions to emerging markets in the Asia Pacific, the Middle East, and Africa.

Regulations around the world are also changing quickly as a result of increased interest in ensuring the rapid commercialization of products with assured safety profiles. Therefore, it has become imperative for manufacturers to provide timely data updates for regulatory submissions and literature. Furthermore, it is anticipated that the market for clinical trials and product registration services will witness rapid growth during the forecast period.

Impending patent expiries and the increasing focus of drug manufacturers on delivering drugs for rare diseases have prompted the emergence of a pipeline for specialty drugs. With an increase in the number of such drug candidates, the demand for clinical trial and product registration services will rise in the coming years.

Asia-Pacific will be the global outsourcing center.

The manufacturers of several blockbuster drugs are domiciled in Europe and North America, where the patents for such drugs are rapidly expiring. Several of these manufacturers have increased their efforts to introduce their drugs and medical devices to Asia Pacific’s emerging markets in order to extend the product life cycle. Companies are capitalizing on the potential of emerging economies to introduce their products and services into developed markets.CDMO and regulatory outsourcing activities are being increasingly set up in emerging economies due to cheap labor, improved skills, and low service costs.

Periods of History and Forecast

This research report presents the analysis of each considered segment for the period from 2016 to 2026, using 2017 as the base year for estimations. Compounded annual growth rates (CAGRs) for each segment are calculated for the forecast period from2018 to 2026.

Report Scope by Segments

The Regulatory Affairs Outsourcing Services market report provides a quantitative assessment of the industry in terms of current and forecasted market size while also presenting the market dynamics. This market is segmented based on types, usage areas, and geography.

This report also includes a company profiles section that gives insights into the company overview, product portfolio, financial information, and key developments of major market players. The major players profiled in this report include ICON plc, Quintiles Transnational Corporation, PAREXEL International Corporation, Covance, Inc., Clinilabs, Inc., Charles River Laboratories International, Inc., Accell Clinical Research, LLC, Criterium, Inc., Medpace, Inc., Promedica International, WuXi App Tec, Genpact Ltd., PRA Health Sciences, Inc., and Pharmaceutical Product Development (PPD), LLC.

Key questions are answered in this report.

• What is the current and projected size of the global market for regulatory affairs outsourcing services through 2026?
• Which are the key trends observed in the global market, along with the most prominent growth facilitators?
• What are the major strategic initiatives undertaken by the major market participants to ensure global market stability?
• What are the key contributing factors to the dominance of North America and Europe in the global market?
• Which factors contribute to the rapid growth of the Asia-Pacific market?
• Which service type is currently in huge demand from drug manufacturers and why?

Chapter 1. Preface
1.1. Report Description
1.1.1. Study Purpose
1.1.2. Target Audience
1.1.3. USP and Key Offerings
1.2. Research Scope
1.3. Research Methodology
1.3.1. Phase I – Secondary Research
1.3.2. Phase II – Primary Research
1.3.3. Approach Adopted
1.3.4. Top Down Approach
1.3.5. Bottom Up Approach
1.3.6. Phase III – Expert Panel Review
1.3.7. Assumptions
1.4. Market Segmentation

Chapter 2. Executive Summary
2.1. Global RAOS Market Portraiture
2.2. Global RAOS Market, by Type, 2017 (US$ Mn)
2.3. Global RAOS Market, by Geography, 2017 (US$ Mn)

Chapter 3. Global Regulatory Affairs Outsourcing Services (RAOS) Market: Dynamics and Future Outlook
3.1. Overview
3.2. Industry Pros and Cons
3.3. Drivers
3.4. Challenges
3.5. Opportunities
3.6. Porter’s Five Forces Analysis
3.7. Major Agreements and Strategic Alliances
3.8. Attractive Investment Proposition, by Geography, 2017
3.9. Competitive Analysis: Global RAOS Market, by Key Players, 2017

Chapter 4. Global Regulatory Affairs Outsourcing Services (RAOS) Market, by Type, 2016 – 2026 (US$ Mn)
4.1. Overview
4.2. Regulatory Writing & Publishing
4.3. Regulatory Consulting
4.4. Clinical Trial & Product Registration
4.5. Legal Representation
4.6. Other Services

Chapter 5. Global Regulatory Affairs Outsourcing Services (RAOS) Market, by Geography, 2016 – 2026 (US$ Mn)
5.1. Overview
5.2. North America RAOS Market, 2016 – 2026 (US$ Mn)
5.2.1. North America RAOS Market, by Type, 2016 – 2026 (US$ Mn)
5.2.2. North America RAOS Market, by Country, 2016 – 2026 (US$ Mn)
5.2.2.1. U.S.
5.2.2.2. Canada
5.3. Europe RAOS Market, 2016 – 2026 (US$ Mn)
5.3.1. Europe RAOS Market, by Type, 2016 – 2026 (US$ Mn)
5.3.2. Europe RAOS Market, by Country/Region, 2016 – 2026 (US$ Mn)
5.3.2.1. U.K.
5.3.2.2. Germany
5.3.2.3. France
5.3.2.4. Italy
5.3.2.5. Rest of Europe
5.4. Asia Pacific RAOS Market, 2016 – 2026 (US$ Mn)
5.4.1. Asia Pacific RAOS Market, by Type, 2016 – 2026 (US$ Mn)
5.4.2. Asia Pacific RAOS Market, by Country/Region, 2016 – 2026 (US$ Mn)
5.4.2.1. China
5.4.2.2. Japan
5.4.2.3. India
5.4.2.4. Australia
5.4.2.5. Rest of Asia Pacific
5.5. Latin America RAOS Market, 2016 – 2026 (US$ Mn)
5.5.1. Latin America RAOS Market, by Type, 2016 – 2026 (US$ Mn)
5.5.2. Latin America RAOS Market, by Country/Region, 2016 – 2026 (US$ Mn)
5.5.2.1. Brazil
5.5.2.2. Mexico
5.5.2.3. Rest of Latin America
5.6. Middle East & Africa RAOS Market, 2016 – 2026 (US$ Mn)
5.6.1. Middle East & Africa RAOS Market, by Type, 2016 – 2026 (US$ Mn)
5.6.2. Middle East & Africa RAOS Market, by Region, 2016 – 2026 (US$ Mn)
5.6.2.1. GCC
5.6.2.2. South Africa
5.6.2.3. Rest of Middle East & Africa

Chapter 6. Company Profiles
6.1. ICON plc
6.1.1. Company Overview
6.1.2. Financial Information (Subject to Data Availability)
6.1.3. Product Portfolio
6.1.4. Key Developments
6.2. Quintiles Transnational Corporation
6.3. PAREXEL International Corporation
6.4. Covance, Inc.
6.5. Clinilabs, Inc.
6.6. Charles River Laboratories International, Inc.
6.7. Accell Clinical Research, LLC
6.8. Criterium, Inc.
6.9. Medpace, Inc.
6.10. Promedica International
6.11. WuXi App Tec
6.12. Genpact Ltd
6.13. PRA Health Sciences, Inc.
6.14. Pharmaceutical Product Development (PPD), LLC

List of Figures

FIG 1. Regulatory Affairs Outsourcing Services (RAOS) Market: Research Methodology
FIG 2. Market Size Estimation – Top Down & Bottom up Approach
FIG 3. RAOS: Market Segmentation
FIG 4. Global RAOS Market, by Type, 2017 (US$ Mn)
FIG 5. Global RAOS Market, by Geography, 2017 (US$ Mn)
FIG 6. Attractive Investment Proposition, by Geography, 2017
FIG 7. Competitive Analysis: Global RAOS Market, by Key Players, 2017
FIG 8. Global Regulatory Writing & Publishing Services Market, 2016 – 2026 (US$ Mn)
FIG 9. Global Regulatory Consulting Services Market, 2016 – 2026 (US$ Mn)
FIG 10. Global Clinical Trial & Product Registration Services Market, 2016 – 2026 (US$ Mn)
FIG 11. Global Legal Representation Services Market, 2016 – 2026 (US$ Mn)
FIG 12. Global Other RAOS Market, 2016 – 2026 (US$ Mn)
FIG 13. U.S. RAOS Market, 2016 – 2026 (US$ Mn)
FIG 14. Canada RAOS Market, 2016 – 2026 (US$ Mn)
FIG 15. U.K. RAOS Market, 2016 – 2026 (US$ Mn)
FIG 16. Germany RAOS Market, 2016 – 2026 (US$ Mn)
FIG 17. France RAOS Market, 2016 – 2026 (US$ Mn)
FIG 18. Italy RAOS Market, 2016 – 2026 (US$ Mn)
FIG 19. Rest of Europe RAOS Market, 2016 – 2026 (US$ Mn)
FIG 20. China RAOS Market, 2016 – 2026 (US$ Mn)
FIG 21. Japan RAOS Market, 2016 – 2026 (US$ Mn)
FIG 22. India RAOS Market, 2016 – 2026 (US$ Mn)
FIG 23. Australia RAOS Market, 2016 – 2026 (US$ Mn)
FIG 24. Rest of Asia Pacific RAOS Market, 2016 – 2026 (US$ Mn)
FIG 25. Brazil RAOS Market, 2016 – 2026 (US$ Mn)
FIG 26. Mexico RAOS Market, 2016 – 2026 (US$ Mn)
FIG 27. Rest of Latin America RAOS Market, 2016 – 2026 (US$ Mn)
FIG 28. GCC RAOS Market, 2016 – 2026 (US$ Mn)
FIG 29. South Africa RAOS Market, 2016 – 2026 (US$ Mn)
FIG 30. Rest of Middle East and Africa RAOS Market, 2016 – 2026 (US$ Mn)

List of Tables

TABLE 1. Global Regulatory Affairs Outsourcing Services (RAOS) Market Portraiture
TABLE 2. Global RAOS Market, by Type, 2016 – 2026 (US$ Mn)
TABLE 3. Global RAOS Market, by Geography, 2016 – 2026 (US$ Mn)
TABLE 4. North America RAOS Market, by Type, 2016 – 2026 (US$ Mn)
TABLE 5. North America RAOS Market, by Country, 2016 – 2026 (US$ Mn)
TABLE 6. Europe RAOS Market, by Type, 2016 – 2026 (US$ Mn)
TABLE 7. Europe RAOS Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 8. Asia Pacific RAOS Market, by Type, 2016 – 2026 (US$ Mn)
TABLE 9. Asia Pacific RAOS Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 10. Latin America RAOS Market, by Type, 2016 – 2026 (US$ Mn)
TABLE 11. Latin America RAOS Market, by Country/Region, 2016 – 2026 (US$ Mn)
TABLE 12. Middle East and Africa RAOS Market, by Type, 2016 – 2026 (US$ Mn)
TABLE 13. Middle East and Africa RAOS Market, by Region, 2016 – 2026 (US$ Mn)
TABLE 14. ICON plc: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 15. Quintiles Transnational Corporation: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 16. PAREXEL International Corporation: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 17. Covance, Inc.: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 18. Clinilabs, Inc.: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 19. Charles River Laboratories International, Inc.: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 20. Accell Clinical Research, LLC: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 21. Criterium, Inc.: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 22. Medpace, Inc.: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 23. Promedica International: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 24. WuXi App Tec: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 25. Genpact Ltd: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 26. PRA Health Sciences, Inc.: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 27. Pharmaceutical Product Development (PPD), LLC: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)
TABLE 28. Patterson Companies, Inc.: Company Snapshot (Company Overview; Financial Information; Product Portfolio; Key Developments)